CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7,264 enrolled
Drug / intervention
Colchicine +4 moredrug
Likely dose
Colchicine 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03048825
NCT03048825Phase 3Completed
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A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients with Myocardial Infarction / SYNERGY Stent Registry - Organization to Assess Strategies for Ischemic Syndromes 9

Population Health Research Institute·interventional·Posted Feb 9, 2017·Updated Oct 15, 2024

In Brief

A Phase 3 clinical trial evaluating Colchicine, Spironolactone, and 3 other interventions for ST Elevation Myocardial Infarction and Non ST Elevation Myocardial Infarction. Completed, enrolled 7,264 participants across 109 sites in 14 countries.

Detailed Summary

The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat myocardial infarction. These treatments address both the culprit artery (PCI with SYNERGY stent) as well as the non-culprit arteries (randomization to routine colchicine and spironolactone).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsST Elevation Myocardial Infarction, Non ST Elevation Myocardial Infarction
CountriesAustralia, Canada, Czechia, Egypt, France, Hungary, Nepal, Netherlands, North Macedonia, Serbia, Spain, Switzerland, United Kingdom, United States
CollaboratorsBoston Scientific Corporation, Canadian Institutes of Health Research (CIHR)

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartFeb 1, 2018
Primary CompletionAug 9, 2024
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 9.4 years ago

Interventions

Colchicinedrug

Colchicine 0.5 mg once daily

Spironolactonedrug

Spironolactone 25 mg once daily

SYNERGY Bioabsorbable Polymer Drug-Eluting Stentdevice

Trial participants who receive a SYNERGY™ Bioabsorbable Polymer Drug-Eluting (everolimus) Stent during their index PCI for STEMI will be included in the SYNERGY Stent Registry.

Colchicine-Placebodrug

Matching Colchicine-placebo once daily

Spironolactone-Placebodrug

Matching Spironolactone-Placebo once daily